ACBSCT recommends that the Secretary recognize hematopoietic transplantation for generally accepted indications as a covered benefit for all Federal programs for which the Secretary has appropriate responsibility and oversight.

This includes autologous and allogeneic blood, marrow and cord blood transplantation. ACBSCT recommends hematopoietic transplantation be included as a required covered service for all federally-funded programs under the Secretary's purview, to the fullest extent allowed by law and that it be included as an "Essential Health Benefit" under provisions of the Patient Protection and Affordable Care Act.

ACBSCT recommends to the Secretary that Medicare reimburse for the acquisition of blood, marrow and cord blood products for hematopoietic transplantation on a cost basis similar to how reimbursement is made for graft acquisition in solid organ transplantation.

Rationale: The current Medicare payment structure seriously under-reimburses the cost of performing hematopoietic transplantation. The cost of graft acquisition is bundled into the overall reimbursement under the current Medicare prospective payment systems for inpatient and outpatient hospital services. This is fundamentally different from how reimbursement is structured for solid organ transplantation. This recommendation is made to improve the alignment of Medicare reimbursements for these costly but life-saving services.

For cord blood units incapable of bearing a full label, ACBSCT recommends the Secretary clarify that the expiration date can be placed on an attached label provided with the unit at time of release to a transplant center.

ACBSCT recommends the Secretary work with FDA to review requirements for licensure in light of concerns over the potential for licensure requirements to result in increased cost and decreased availability of public cord blood units with the goal that FDA urgently meet with the cohort of applicant cord blood banks and representatives of transplant centers to share and resolve specific concerns regarding licensure.

Rationale: ACBSCT is very concerned that FDA requirements for cord blood bank licensure may prohibitively increase the cost of and decrease the availability of public cord blood units for transplantation without necessarily increasing the safety, stability, potency, or purity of the units.

ACBSCT recommends to the Secretary that models for remote collection of cord blood units be allowed with only limited, scientifically justified safety precautions. The Council also recommends that the Secretary allow for cord blood unit collection from routine deliveries without temperature or humidity monitoring of delivery rooms in hospitals approved by the appropriate bodies for hospital accreditation.